Assessment of the Effectiveness of the NECT Program

Not Applicable

• Conditions: Schizophrenia; Social Function; Bipolar Disorder; Borderline Personality Disorder; Self-stigma
• Interventions: Other: Psychiatric interview; Other: Clinical, diagnostic and functional evaluation; Other: neuropsychological assessment; Other: NECT PROGRAM

• Registration Number: NCT03972735
• Lead Sponsor: Hospital Center Alpes-Isère

Brief Summary

Self-stigma refers to the transformation process wherein a person's previously held social identity is progressively replaced by a devalued and stigmatized view of oneself termed "illness identity". Self-Stigma is a severe problem in Serious Mental Illness (SMI). Self-stigma prevalence is high (41.7% of the 1229 participants with SZ and 21.7% of the 1182 participants with mood disorders had moderate to high levels of IS in the GAMIAN-Europe study). Self-stigma was negatively associated with self-esteem, social function, wellbeing, quality of life or personal recovery and positively associated with psychiatric symptoms and depression. Several psychosocial interventions (mostly combinations of psychoeducation and cognitive behaviour therapy) have been designed to reduce self-stigma and its impact on clinical and functional outcomes, with preliminary effects on self-stigma, insight and self-efficacy.

Narrative Enhancement and Cognitive Therapy (NECT) is a manualized structured 20-session group-based intervention . Conducted by two trained facilitators the sessions combine psychoeducation, cognitive restructuring and story-telling exercises to reduce self-stigma. Developed in USA, NECT was adapted in Israel and Sweden. NECT showed effectiveness in reducing self-stigma and in improving self-esteem and quality of life. Despite being effective on changing coping strategies, NECT effectiveness on social function is still unclear.

The present study aims to validate NECT French adaptation and to evaluate its effectiveness on social function, self-stigma, psychiatric symptoms, self-esteem, wellbeing, quality of life and personal recovery in SMI participants (schizophrenia, bipolar disorder, borderline personality disorder)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-31
• Study First Submitted QC: 2019-05-31
• Study First Posted: 2019-06-04
• Status Verified: 2020-02
• Study Start: 2020-02-10
• Last Update Submitted: 2020-02-10
• Last Update Posted: 2020-02-11
• Primary Completion: 2022-09-01
• Study Completion: 2023-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Diagnosis of schizophrenia, schizoaffective disorder, schizotypal disorder, schizophreniform disorder, bipolar I or II disorder, borderline personality disorder (DSM-V criteria, APA, 2013).
• Clinical stability since 3 months (total PANSS score <120, MADRS score <15 and YMRS <12 for patients with schizophrenia and MADRS score <15 and YMRS <12 for patients with bipolar disorder).
• Patients who gave informed consent to participate in the study.
• Affiliated to a social security scheme or beneficiary of such a scheme.

Exclusion Criteria

• Pregnant or lactating women.
• Criteria relating to the associated pathologies entailing particular risks:
• Neurological disorders of vascular, infectious or neurodegenerative origin.
• Taking somatic drugs with a cerebral or mental impact (eg corticosteroids).
• Presence of an associated intellectual disability.
• Prohibited treatments and procedures:
• Subject in exclusion period of another study.
• Simultaneous participation in other programs having an impact on social functioning or self-stigmatization: remediation of social cognition, individual and group care targeting self-stigmatization and training in social skills.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
NECT + follow up	NECT PROGRAM	Narrative Development and Cognitive Therapy (NECT) is a 12 session group-based manualized intervention combining psychoeducation, cognitive restructuring and narrative enhancement. The 2 hours sessions are conducted by two trained facilitators.
TAU	Clinical, diagnostic and functional evaluation	* Drug treatment (antipsychotic, mood stabilizing) for people with schizophrenia or with bipolar disorder * Support in day-care hospital * No intervention specifically targeting self-stigma reduction or improvements in social functioning (social cognitive remediation or social skills training)
NECT + follow up	Clinical, diagnostic and functional evaluation	Narrative Development and Cognitive Therapy (NECT) is a 12 session group-based manualized intervention combining psychoeducation, cognitive restructuring and narrative enhancement. The 2 hours sessions are conducted by two trained facilitators.
NECT + follow up	neuropsychological assessment	Narrative Development and Cognitive Therapy (NECT) is a 12 session group-based manualized intervention combining psychoeducation, cognitive restructuring and narrative enhancement. The 2 hours sessions are conducted by two trained facilitators.
NECT + follow up	Psychiatric interview	Narrative Development and Cognitive Therapy (NECT) is a 12 session group-based manualized intervention combining psychoeducation, cognitive restructuring and narrative enhancement. The 2 hours sessions are conducted by two trained facilitators.
TAU	Psychiatric interview	* Drug treatment (antipsychotic, mood stabilizing) for people with schizophrenia or with bipolar disorder * Support in day-care hospital * No intervention specifically targeting self-stigma reduction or improvements in social functioning (social cognitive remediation or social skills training)
TAU	neuropsychological assessment	* Drug treatment (antipsychotic, mood stabilizing) for people with schizophrenia or with bipolar disorder * Support in day-care hospital * No intervention specifically targeting self-stigma reduction or improvements in social functioning (social cognitive remediation or social skills training)
TAU	NECT PROGRAM	* Drug treatment (antipsychotic, mood stabilizing) for people with schizophrenia or with bipolar disorder * Support in day-care hospital * No intervention specifically targeting self-stigma reduction or improvements in social functioning (social cognitive remediation or social skills training)

Primary Outcome Measures

Name	Time	Method
Personal and Social Performance Scale	Changes between baseline function, at 6, 12 and 18 months of follow-up	Changes in the aggregates (average) of standardized performance levels : z-scores of social function (0 to 100) after NECT Program

Secondary Outcome Measures

Name	Time	Method
Internalized Stigma of Mental Illness (ISMI) scale	Changes between baseline function, at 6, 12 and 18 months of follow-up	self-assessment of internalized stigma (mean score of total self-stigma ranging from 1 to 4)
BIRCHWOOD INSIGHT SCALE	Changes between baseline function, at 6, 12 and 18 months of follow-up	Changes in the aggregates (average) of standardized performance levels
MARS (Medication Adherence Rating Scale)	Changes between baseline function, at 6, 12 and 18 months of follow-up	self-assesment of adherence into treatment (minimum 1-maximum 10)
STORI Stages of Recovery Instrument	Changes between baseline function, at 6, 12 and 18 months of follow-up	Self-assessment of personal recovery (maximum stage of recovery ranging from 0 to 5
WEMWBS (Warwick Edinburgh Mental Well Being Scale) )	Changes between baseline function, at 6, 12 and 18 months of follow-up	self assessment of mental well being
MADRS (Montgomery-Asberg Depression Rating)	Changes between baseline function, at 6, 12 and 18 months of follow-up	Changes in the aggregates (average) of standardized performance levels
Positive and Negative Symptoms Scale for Schizophrenia (PANSS)	Changes between baseline function, at 6, 12 and 18 months of follow-up	Changes in the aggregates (average) of standardized performance levels : z-scores of positive and negative symptoms (minimum score 30- maximum score 210) of schizophrenia after NECT Program
SERS (Self-Esteem Rating Scale)	Changes between baseline function, at 6, 12 and 18 months of follow-up	Changes in the aggregates (average) of standardized performance levels : z-scores (minimum score 10-maximum score 70) in self-assessment of self-esteem
S-QOL (Subjective Quality of Life)	Changes between baseline function, at 6, 12 and 18 months of follow-up	sel-assessment of quality of life (minimum 0, maximum 100)

Trial Locations

Locations (11)

University Hospital, Grenoble; 🇫🇷 Grenoble, Aura, France

CHS Esquirol; 🇫🇷 Limoges, Aura, France

Chs Le Valmont; 🇫🇷 Valence, Aura, France

Ch Annecy-Genevois; 🇫🇷 Annecy, Aura, France

Ch Le Vinatier; 🇫🇷 Bron, Aura, France

CHU de CLERMONT-FERRAND; 🇫🇷 Clermont-Ferrand, Aura, France

Clinique du Dauphiné; 🇫🇷 Seyssins, Aura, France

E.P.S.M. Ariane; 🇫🇷 Caen, Normandie, France

Hopital La Colombière, University Hospital Montpellier; 🇫🇷 Montpellier, Occitanie, France

Hospital Center SAINTE MARIE; 🇫🇷 Nice, Paca, France

Service des Specialités psychiatriques; 🇨🇭 Geneva, Switzerland